SIST EN ISO 13485:2003/AC:2009
(Corrigendum)Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003/Cor 1:2009)
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003/Cor 1:2009)
This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The primary objective of this International Standard is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001 (see Annex B).
Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke (ISO 13485:2003/Cor 1:2009)
Dispositifs médicaux - Systèmes de manegement de la qualité - Exigences à des fins réglementaires (ISO 13485:2003/Cor 1:2009)
Medicinski pripomočki - Sistemi vodenja kakovosti - Zahteve za zakonodajne namene (ISO 13485:2003/Cor 1:2009)
General Information
- Status
- Withdrawn
- Publication Date
- 17-Nov-2009
- Withdrawal Date
- 12-Mar-2012
- Technical Committee
- VAZ - Healthcare
- Current Stage
- 9900 - Withdrawal (Adopted Project)
- Start Date
- 13-Mar-2012
- Due Date
- 05-Apr-2012
- Completion Date
- 13-Mar-2012
Relations
- Effective Date
- 27-Jun-2009
- Effective Date
- 01-Apr-2012
- Effective Date
- 08-Jun-2022
Frequently Asked Questions
SIST EN ISO 13485:2003/AC:2009 is a corrigendum published by the Slovenian Institute for Standardization (SIST). Its full title is "Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003/Cor 1:2009)". This standard covers: This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The primary objective of this International Standard is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001 (see Annex B).
This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The primary objective of this International Standard is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001 (see Annex B).
SIST EN ISO 13485:2003/AC:2009 is classified under the following ICS (International Classification for Standards) categories: 03.100.70 - Management systems; 11.020.01 - Quality and environmental management in health care. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN ISO 13485:2003/AC:2009 has the following relationships with other standards: It is inter standard links to SIST EN ISO 13485:2003/AC:2008, SIST EN ISO 13485:2012, SIST EN ISO 13485:2003. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN ISO 13485:2003/AC:2009 is associated with the following European legislation: EU Directives/Regulations: 90/385/EEC, 93/42/EEC, 98/79/EC; Standardization Mandates: M/BC/CEN/89/9. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.NRQRGDMQHMedizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke
(ISO 13485:2003/Cor 1:2009)Dispositifs médicaux - Systèmes de manegement de la qualité - Exigences à des fins réglementaires (ISO 13485:2003/Cor 1:2009)Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003/Cor 1:2009)11.040.01Medicinska oprema na splošnoMedical equipment in general03.120.10Vodenje in zagotavljanje kakovostiQuality management and quality assuranceICS:Ta slovenski standard je istoveten z:EN ISO 13485:2003/AC:2009SIST EN ISO 13485:2003/AC:2009en,fr,de01-december-2009SIST EN ISO 13485:2003/AC:2009SLOVENSKI
STANDARDSIST EN ISO 13485:2003/AC:20081DGRPHãþD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 13485:2003/AC
August 2009
Août 2009
August 2009 ICS 03.120.10; 11.040.01 English version Version Française Deutsche Fassung
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003/Cor 1:2009)
Dispositifs médicaux - Systèmes de manegement de la qualité - Exigences à des fins réglementaires (ISO 13485:2003/Cor 1:2009)
Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke
(ISO 13485:2003/Cor 1:2009) This corrigendum becomes effective on 26 August 2009 for incorporation in the three official language versions of the EN.
Ce corrigendum prendra effet le 26 août 2009 pour incorporation dans les trois versions linguistiques officielles de la EN.
Die Berichtigung tritt am 26. August 2009 zur Einarbeitung in die drei offiziellen Sprachfassungen der EN in Kraft. CEN Management Centre: CENELEC Central Secretariat:Avenue Marnix 17, B-1000 Brüssel Avenue Marnix 17, B-1000 Brüssel© 2009 CEN/CENELEC All rights of exploitation in any form and by any means reserved worldwide for CEN national Members and for CENELEC Members. Tous droits d'exploitation sous quelque forme et de quelque manière que ce soit réservés dans le monde entier aux membres nationaux du CEN et aux membres du CENELEC. Alle Rechte der Verwertung, gleich in welcher Form und in welchem Verfahren, sind weltweit den nationalen Mitgliedern von CEN und den Mitgliedern von CENELEC vorbehalten. Ref. No. EN ISO 13485:2003/AC:2009 D/E/F SIST EN ISO 13485:2003/AC:2009
Module D Permissible exclusions Module E Permissible exclusions for conformity of "product quality assurance" Module H Permissible exclusions SIST EN ISO 13485:2003/AC:2009
8 Modification to the endorsement notice Delete the note. 9 Modification to Annex ZA Replace Annex ZA with the following:
"Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC
This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Associati
...
La norme SIST EN ISO 13485:2003/AC:2009 spécifie des exigences pour un système de gestion de la qualité dans le domaine des dispositifs médicaux. Son champ d'application est particulièrement crucial puisqu'elle vise à démontrer la capacité d'une organisation à fournir des dispositifs médicaux et des services connexes qui répondent de manière cohérente aux exigences des clients et aux exigences réglementaires applicables. Cette norme est essentielle pour garantir que les produits médicaux respectent les standards de qualité nécessaires et que les processus soient en adéquation avec les réglementations en vigueur. Parmi les forces de cette norme, on note sa capacité à faciliter l'harmonisation des exigences réglementaires relatives aux dispositifs médicaux. En intégrant des exigences spécifiques aux dispositifs médicaux et en excluant certaines exigences de la norme ISO 9001 qui ne sont pas pertinentes dans un contexte réglementaire, SIST EN ISO 13485:2003/AC:2009 se positionne comme un outil adapté pour les organisations opérant dans le secteur médical. Cette spécificité permet aux entreprises de mieux se concentrer sur les aspects critiques de la qualité qui impactent directement la sécurité et l'efficacité des dispositifs médicaux. La pertinence de la norme ne se limite pas seulement à son contenu, mais s'étend également à son application dans des environnements de plus en plus réglementés, où la conformité est essentielle. En effet, les établissements de santé et les industriels sont sous pression pour démontrer leur conformité aux exigences rigoureuses du marché. La norme SIST EN ISO 13485:2003/AC:2009 constitue donc un cadre solide qui aide ces organisations à non seulement se conformer aux exigences réglementaires, mais également à améliorer continuellement leurs processus de qualité. En résumé, la SIST EN ISO 13485:2003/AC:2009 représente un standard fondamental pour les dispositifs médicaux et leurs systèmes de gestion. Son approche axée sur les exigences réglementaires, combinée à des aspects spécifiques aux dispositifs médicaux, en fait un outil incontournable pour toutes les organisations cherchant à maintenir des normes élevées de qualité et de conformité dans ce secteur critique.
Die SIST EN ISO 13485:2003/AC:2009 legt einen klaren Rahmen für Qualitätsmanagementsysteme fest, die für medizinische Geräte und damit verbundene Dienstleistungen angewendet werden. Dieses Dokument hat einen weitreichenden Geltungsbereich, der es Organisationen ermöglicht, ihre Fähigkeit zur Bereitstellung von medizinischen Geräten nachzuweisen, die den Kundenanforderungen sowie den regulatorischen Anforderungen entsprechen. Der Standard hebt sich durch seine spezifischen Anforderungen hervor, die auf die Besonderheiten der Medizinproduktebranche abgestimmt sind. Ein wesentliches Merkmal dieser Norm ist die Förderung harmonisierter regulatorischer Anforderungen für Qualitätsmanagementsysteme im Bereich medizinischer Geräte. Dadurch wird sichergestellt, dass die Unternehmen nicht nur den technischen Anforderungen gerecht werden, sondern auch die gesetzlichen Vorgaben in verschiedenen Märkten einhalten. Ein weiterer Vorteil des Standards ist die Möglichkeit, dass er Organisationen hilft, einen Wettbewerbsvorteil zu erlangen, indem sie sich an international anerkannten Anforderungen orientieren, was zur Verbesserung ihrer Glaubwürdigkeit und Marktakzeptanz führt. Zudem enthält die Norm spezifische Ausschlüsse im Vergleich zur ISO 9001, was bedeutet, dass nicht alle Anforderungen dieser allgemeinen Qualitätsmanagementnorm anwendbar sind. Diese Fokussierung erlaubt es den Organisationen, sich besser auf die spezifischen Herausforderungen und Anforderungen in der Medizinprodukteindustrie zu konzentrieren. Allerdings ist es wichtig zu beachten, dass Organisationen, deren Qualitätsmanagementsysteme dieser Norm entsprechen, nicht automatisch die Konformität zu ISO 9001 beanspruchen können, es sei denn, sie erfüllen alle Anforderungen dieser Norm, wie in Anhang B dargelegt. Insgesamt ist die SIST EN ISO 13485:2003/AC:2009 ein entscheidendes Instrument für Organisationen im medizinischen Sektor, um eine qualitätsorientierte Herangehensweise in der Entwicklung und Bereitstellung von Medizinprodukten sicherzustellen. Sie bietet eine solide Grundlage zur Verbesserung der Prozesse und zur Erfüllung der strengen gesetzlichen Anforderungen, was für die Sicherheit und Wirksamkeit der medizinischen Produkte von zentraler Bedeutung ist.
SIST EN ISO 13485:2003/AC:2009は、医療機器に関連する品質管理システムにおける要求事項を詳細に定義した国際標準です。この標準の範囲は、医療機器及びその関連サービスの提供者が、顧客の要求事項や医療機器に関連する規制要求事項を一貫して満たす能力を示すために必要な品質管理システムの要件を明確にしています。 この標準の強みは、医療機器の品質管理システムに特化した要求を含むことで、特に医療分野における規制要件の調和を図る点です。医療機器業界は、厳格な規制が適用されるため、ISO 9001の一般的な要求の中で医療機器に不適切とされる要素を除外することにより、より具体的で適切な基準を提供しています。この点において、SIST EN ISO 13485:2003/AC:2009は、医療機器メーカーや関連サービス提供者にとって非常に関連性の高い標準です。 また、ISO 9001に準拠していると主張するには、全ての要求事項に従う必要があることから、組織が医療機器の製造およびサービスに特有の要件を満たすことの重要性が強調されています。このように、SIST EN ISO 13485:2003/AC:2009は、医療機器の品質向上と安全性確保に寄与し、医療機器産業の信頼性を高めるために不可欠な基準となっています。
SIST EN ISO 13485:2003/AC:2009는 의료기기 품질 관리 시스템을 위한 국제표준으로, 기업이 고객의 요구사항 및 의료기기와 관련된 규정 요구사항을 일관되게 충족시키기 위한 품질 관리 시스템의 요건을 명확히 규정하고 있습니다. 이 표준의 주된 목적은 의료기기 품질 관리 시스템에 대한 규제 요구사항의 조화를 촉진하는 것입니다. 이 표준의 강점은 무엇보다도 의료기기와 관련된 서비스의 품질을 보장하는 데 필수적인 특정 요구사항을 포함하고 있다는 점입니다. 따라서, 의료기기 제조업체는 고객과 규제 기관의 요구에 부합하는 품질 관리 시스템을 구축하고 유지하는 데 필요한 기반을 제공받게 됩니다. 또한 ISO 9001의 요구사항 중 규제 요구와 관련이 없는 일부는 제외되어 있기에, 더 명확하고 구체적인 규제가 필요할 때 유용합니다. 이 점은 기업이 자신들의 품질 관리 시스템이 ISO 9001에 일치한다고 주장할 수 없도록 하여, 오히려 품질 관리 시스템의 특화된 적용을 강조합니다. SIST EN ISO 13485:2003/AC:2009의 적용은 의료기기 산업에서 매우 중요하며, 이는 고객의 안전과 만족을 보장하는 데 필수적입니다. 의료기기 관련 기업이 이 표준을 준수함으로써 얻는 이점은 지속적인 품질 개선과 규제 준수 확립에 기여하여, 궁극적으로는 시장에서의 경쟁력을 강화하는 데 큰 역할을 합니다. 이러한 측면에서 SIST EN ISO 13485:2003/AC:2009는 의료기기 품질 관리 시스템의 필수적인 지침서로서 그 중요성이 결코 간과될 수 없습니다.
The SIST EN ISO 13485:2003/AC:2009 standard provides comprehensive guidelines for establishing a quality management system specifically tailored for organizations involved in the production and servicing of medical devices. Its scope is focused on ensuring that organizations can consistently demonstrate their ability to meet both customer requirements and the regulatory requirements for medical devices, making it immensely relevant in today's highly regulated healthcare landscape. One of the key strengths of this standard is its emphasis on harmonizing regulatory requirements across different jurisdictions, which can significantly reduce the complexity organizations face when navigating multiple regulatory environments. By aligning with this standard, organizations enhance their ability to manage quality processes effectively while ensuring compliance with necessary regulations. Additionally, the exclusion of certain ISO 9001 requirements deemed inappropriate for regulatory purposes allows organizations to streamline their quality management processes in a way that is specifically conducive to the medical device sector. This tailored approach enhances operational efficiency and focuses resources on meeting the unique challenges and standards inherent to medical device manufacturing. Another important aspect is that the standard provides organizations with a clear framework to establish and maintain a quality management system that not only fulfills regulatory obligations but also supports continual improvement and customer satisfaction, reinforcing the critical role that quality management systems play in the success of medical device companies. Overall, the SIST EN ISO 13485:2003/AC:2009 standard stands as a pivotal element in the medical device industry, facilitating compliance with rigorous quality management criteria while promoting the delivery of safe and effective medical devices and related services.
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